Many craniofacial surgical procedures involve both functional and aesthetic reconstruction for successful completion. The need for soft tissue fill for additional functionality and contouring is an aspect that can have lower priority during reconstructive craniofacial surgeries. Following the major tissue reconstruction, this secondary phase of the procedure is of critical importance to the long term outcome. The current methods of using autologous fat as a fill material, lead to unpredictable and non-reproducible end tissue volume and physical properties. These were key factors in Luna Innovations'Phase I research plan that demonstrated in vitro and in vivo feasibility of an innovative approach to process tissue to achieve a more effective and reproducible volumes and tissue viability during autologous free fat transplantation (AFT) and tissue engineering. The goal of the Phase II is to refine the preliminary results and develop a clinically relevant standard procedure to process a patient's adipose tissue mechanically and/or chemically to force out the lipids prior to transplanting, where the body will convert the tissue back to functional, healthy adipose. This technology has promise to improve the clinical outcomes of end volume and texture with increased predictability and reproducibility over currently used AFT practices. Ultimately, the clinical system will consist of a fully automated and programmable bioreactor to perform the tissue processing that will produce more effective, more predictable and more reproducible soft tissue reconstruction while eliminating any rejection and allergic reactions. PUBLIC HEALTH RELEVANCE: Many reconstructive challenges associated with craniofacial procedures are characterized by a lack of soft tissue 'fill'and/or symmetry. The goal of this Phase II proposal is validate a method for in vitro mechanical delipidation of adipose tissue in preparation for autologous free fat transplantations and design the necessary fully-automated bioreactor. The novel methodology will lead to a more effective and reproducible enhancement and augmentation. Once commercialized, this technology has great medical potential in reconstructive and cosmetic applications as well as wound healing.